Last updated: 11/07/2018 17:13:36
Injection Site Study In Patients With Type 2 Diabetes Mellitus (T2DM) And Healthy Volunteers
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An Open-Label, Randomized, Multi-Site Study to Assess the Pharmacokinetics of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered at Three Different Injection Sites in Adult Male and Female Subjects with Type 2 Diabetes and of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered in the Abdomen of Healthy, Normal Volunteers
Trial description: This study is an open-label study in healthy volunteers and in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream after a single dose given at different injection sites, and the impact this medication has on various substances in the blood. Assessments include ECGs, vital signs, repeat blood sampling and monitoring of any side effects.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Pharmacokinetic measurements for different injection sites after one dose.
Timeframe: Pre-dose, 6, 24, 48, 96, 216, 312, 480, 672 and 984 hours
Secondary outcomes:
Pharmacodynamic measurements at three different times after one dose.
Timeframe: Up to Day 29
Interventions:
Drug: GSK716155 subcutaneous injections
Enrollment:
63
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Jessica E. Matthews, Murray W. Stewart, Erika H. De Boever, Robert L. Dobbins, Rebecca J. Hodge, Susan E. Walker, M. Claire Holland, Mark A. Bush, for the Albiglutide Study Group . Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Albiglutide, a Long-Acting Glucagon-Like Peptide-1 Mimetic, in Patients with Type 2 Diabetes. The Journal of Clinical Endocrinology & Metabolism. 2008;93(12):4810-4817.
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
Not applicable
Study date(s)
October 2006 to March 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 75 years
Accepts healthy volunteers
Yes
- They can be healthy volunteers or subjects with type 2 diabetes mellitus that has been diagnosed for at least three months. T2DM subjects must be taking either (1) no medication for their diabetes or (2) taking metformin or (3) taking a TZD (thiazolidinedione).
- Subjects must have a BMI between 25 and 40 kg/m² and weigh at least 50kg.
- Bloodwork that meets certain criteria (for example, total cholesterol > 240 mg/dL)
- Clinically significant hepatic enzyme elevation
Inclusion and exclusion criteria
Inclusion criteria:
- They can be healthy volunteers or subjects with type 2 diabetes mellitus that has been diagnosed for at least three months. T2DM subjects must be taking either (1) no medication for their diabetes or (2) taking metformin or (3) taking a TZD (thiazolidinedione).
- Subjects must have a BMI between 25 and 40 kg/m² and weigh at least 50kg.
- Women must be of non-childbearing potential.
Exclusion criteria:
- Bloodwork that meets certain criteria (for example, total cholesterol > 240 mg/dL)
- Clinically significant hepatic enzyme elevation
- HbA1c less than 6.5 or greater than 10
- Positive test result for Hepatitis B surface antigen, positive Hepatitis C or HIV
- Any major illness other than diabetes
- Previous use of insulin as treatment for diabetes
- Significant renal disease as defined by screening lab tests
- History of drug or other allergy which in the opinion of the investigator contradicts subject participation
- Smoking or use of nicotine-containing products within the previous 6 months
- History of alcohol or drug abuse
- Unwilling to abstain from alcohol prior to and during the in-patient clinic stays
- Unwilling to abstain from caffeine- or xanthine-containing products prior to and during the in-patient clinic stays
- Use of St. John's Wort during the study
- Has donated 500 nL or more blood within 56 days of dosing or plans to donate blood in the month following study participation.
Trial location(s)
Location
GSK Investigational Site
Orlando, Florida, United States, 32809
Status
Study Complete
Location
GSK Investigational Site
Morrisville, North Carolina, United States, 27560
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94598
Status
Study Complete
Location
GSK Investigational Site
Miramar, Florida, United States, 33025
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-20-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Results for study GLP107724 can be found on the GSK Clinical Study Register.
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